ATHEROGENICS PROVIDES UPDATE ON AGI-1067 CLINICAL PROGRAM

AtheroGenics has provided an update on its AGI-1067 clinical program for the treatment of atherosclerosis in patients with coronary artery disease.

The drug is currently being tested in a pivotal Phase III clinical trial, called ARISE, at leading cardiovascular research centers throughout the U.S., Canada, the UK and South Africa.

AtheroGenics has submitted to the FDA proposed amendments to the ARISE clinical trial protocol designed to enhance the trial as well as to accelerate the current pace of the trial. Subject to approval by the FDA, in a manner that would not adversely affect the special protocol assessment for AGI-1067, AtheroGenics intends to increase patient enrollment in ARISE to a target of 6,000 patients from the current target of 4,000 patients, thus providing an estimated 50 percent increase to 10,000 patient-years of exposure during the course of the trial.

At the current rate of enrollment, the company estimates that the trial would achieve full patient enrollment by mid-2005. Given the increased size and longer duration of the trial, the company has also proposed to eliminate the minimum 12-month follow-up period for subjects.